ITY · Assembly, Tube Housing, X-Ray, Diagnostic
Radiology · 21 CFR 892.1760 · Class 1
Overview
| Product Code | ITY |
|---|---|
| Device Name | Assembly, Tube Housing, X-Ray, Diagnostic |
| Regulation | 21 CFR 892.1760 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Dynarad Corp. | Feb 10, 2000 | SESE |
| K933162 | MRX-750 | Mrx Corp. | Oct 7, 1993 | SESE |
| K923094 | MOLYBDENUM | Southeastern Medical Diagnostics, Inc. | Mar 4, 1993 | SESE |
| K923141 | PHILIPS PRE-FILTER OPTION | Philips Medical Systems, Inc. | Jan 21, 1993 | SESE |
| K921129 | MRX-700 | Mrx-Ray Tube Corp. | Oct 5, 1992 | SESE |
| K921130 | MRX-865 | Mrx-Ray Tube Corp. | Sep 10, 1992 | SESE |
| K921316 | MG-1001 TUBE HOUSING ASSEMBLY | Magma Corp. | Jun 22, 1992 | SESE |
| K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | Shimadzu Medical Systems | May 29, 1992 | SESE |
| K920724 | HIGH SPEED ROTATION STARTER SA-50 | Shimadzu Medical Systems | Apr 27, 1992 | SESE |
| K920723 | HIGH SPEED ROTATION STARTER SA-40 | Shimadzu Medical Systems | Apr 27, 1992 | SESE |
| K920387 | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | Shimadzu Medical Systems | Apr 14, 1992 | SESE |
| K913987 | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Codman & Shurtleff, Inc. | Apr 13, 1992 | SESE |
| K913301 | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | Comet North America, Inc. | Aug 28, 1991 | SESE |
| K912338 | TUBE HOUSING ASSEMBLIES | Comet Ltd. C/O Radiology Resources, Inc. | Aug 7, 1991 | SESE |
| K911695 | VARIOUS X-RAY TUBES | Comet Ltd. C/O Radiology Resources, Inc. | Jun 19, 1991 | SESE |
| K910308 | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 | Inmark Corp. | Mar 27, 1991 | SESE |
| K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT | Comet Ltd. C/O Radiology Resources, Inc. | Mar 6, 1991 | SESE |
| K910276 | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 | Inmark Corp. | Mar 6, 1991 | SESE |
| K904182 | R-800-SF | Advantech | Nov 13, 1990 | SESE |
| K900367 | HOFMANN-NAGEL (HOFNA) X-RAY TUBES | Hofmann | Feb 26, 1990 | SESE |
Top Applicants
- Shimadzu Medical Systems — 4 clearances
- Inmark Corp. — 4 clearances
- X-Ray Tube Corp. — 3 clearances
- Comet Ltd. C/O Radiology Resources, Inc. — 3 clearances
- Siemens Corp. — 2 clearances
